Physical Activity Pain Resilience

NCT07049029 | Recruiting

• 2 other identifiers: STUDY00004982K23AR078337
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test a new program called Pain REsilience Promotion for Youth (PREP-Y). This program is designed to help adolescents with chronic musculoskeletal pain (pain in muscles, bones, or joints that lasts more than 3 months) become more physically active and better able to manage their pain. The program includes four weekly virtual sessions that teach skills related to resilience, such as how to stay motivated, build confidence, and cope with pain. Participants will complete surveys and physical activity tests before and after the program. Participants will also wear physical activity monitors to track their activity levels. The goal of this study is to learn whether the program is practical, helpful, and acceptable to participants, and to prepare for a future larger study.

Conditions

Chronic Pain

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intervention

  Fidelity checklists detailing content areas of the intervention adequately conveyed during the study visit will be used to measure intervention feasibility.

  From enrollment to the post-treatment visit, for a total of 6 weeks

• Acceptability of Intervention

  Number of intervention visits completed by participants will be used to determine how acceptable the intervention is to the target population.

  From enrollment to the post-treatment visit, for a total of 6 weeks

Secondary Outcomes (2)

• Accelerometry Data

  From baseline to 3-month follow-up, for a total of 18 weeks

• Functional Disability Inventory

  From baseline to 3-month follow-up, for a total of 18 weeks

Study Arms (1)

PREP-Y

EXPERIMENTAL

Behavioral: PREP-Y

Interventions

PREP-Y BEHAVIORAL

The intervention is a series of behavioral health/psychoeducational modules that the participant will learn from. Participants will use the information discussed and overall impact on physical activity engagement, chronic pain management, and quality of life will be measured

PREP-Y

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 12 and 17
• History of chronic musculoskeletal pain for more than 3 months assessed by a pediatric rheumatologist or pain physician
• Diagnosis of a primary pain disorder (e.g., juvenile fibromyalgia and other widespread pain conditions, lower back pain, complex regional pain and amplified pain syndrome)
• Speaks English as primary language

You may not qualify if:

• Chronic pain secondary to disease (e.g., sickle cell disease or rheumatic disease such as juvenile arthritis, systemic lupus erythematosus)
• Presence of an untreated major psychiatric diagnosis (e.g., major depression, bi-polar disorder, psychoses)
• History or diagnosis of developmental delay.

Sponsors & Collaborators

• William Black: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Black, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Black, PhD

CONTACT

614-472-0717; william.black@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 3, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-06

Locations

US (1)